Surgical access assembly and method of using same

ABSTRACT

A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either within the brain. Once positioned at a desired location, the obturator is removed, leaving a distal end of the outer sheath adjacent an area of interest, and creating a working corridor. Interrogation of the area of interest may be performed to evaluate a disorder and/or abnormality, as well as evaluate treatment regimes. Interventional devices may also be introduced to the area of interest, as well as a variety of treatments.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of U.S. patent application Ser. No.16/102,416 filed on Aug. 13, 2018, which application is a continuationof application Ser. No. 13/474,433 filed on May 17, 2012, now abandoned,which is a continuation-in-part of application Ser. No. 13/444,722 filedon Apr. 11, 2012, now U.S. Pat. No. 9,579,121, which is acontinuation-in-part of application Ser. No. 13/444,713, filed on Apr.11, 2012, now U.S. Pat. No. 9,186,175, which is a continuation-in-partof application Ser. No. 13/444,732, filed on Apr. 11, 2012, now U.S.Pat. No. 9,625,523, said application Ser. No. 13/444,713 is acontinuation-in-part of application Ser. No. 13/280,015 filed on Oct.24, 2011, now U.S. Pat. No. 9,770,261, which is a continuation-in-partof application Ser. No. 11/665,666 filed on Oct. 28, 2005, nowabandoned, filed as application No. PCT/US05/39185 on Oct. 28, 2005.PCT/US05/39185 is a claims the benefit of application 60/623,094 filedon Oct. 28, 2004. The entire contents of these applications areincorporated herein by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates generally to a surgical device for usewith delicate and critical tissues, as well as methods of accessing andperforming surgery using same. The present disclosure also relates totreatment of a surgical site.

BACKGROUND

Diagnosis and treatment of conditions affecting the brain are among themost difficult and complex problems that face the medical profession.The brain is a complex and delicate soft multi-component tissuestructure that controls bodily functions through a complex neuralnetwork connected to the rest of the body through the spinal cord. Thebrain and spinal cord are contained within and protected by significantbony structures, e.g., the skull and the spine. Given the difficulty ofaccessing the brain through the hard bony protective skull and thedelicate network and complex interactions that form the neuralcommunication network contained within the brain that define the humanbody's ability to carry on its functions of speech, sight, hearing,functional mobility, reasoning, emotions, respiration, hormonal andother metabolic functions, the diagnosis and treatment of disorders thatare affected by abnormalities of the CNS and/or brain function presentsunique challenges not encountered elsewhere in the body.

For example, abnormalities such as intracranial cerebral hematomas(ICH), abscesses, glioblastomas (GB), and metastases (mets) manifestthemselves in the intraparenchymal subcortical space (i.e., the whitematter) of the brain are particularly challenging to access, let alonetreat. Similarly, functional diseases/abnormalities, such as, forexample, Alzheimer's, Parkinson's, epilepsy, bi-polar, depression, whichalso have origins in hard to access areas of the brain, are alsodifficult to access and subsequently treat. Central nervous system(“CNS”) based disease/abnormalities, and metabolic/regulatory systemicconditions that result, for example, obesity, hormone regulatedconditions, insulin production and subsequent flow/perfusion into thebody, etc., also have root causes within the brain, as do addictions andthe recognition of and response to pain stimulus. Indeed, the locationto access the area in the brain where the functionaldiseases/abnormalities, CNS based disease/abnormalities,metabolic/regulatory systemic conditions, and pain recognition, isdifficult to reach, or even apply therapy thereto. For example, thehemispheres of the brain contain eloquent communication structures(neural network) which are located in the subcortical space, calledfiber tracts and fascicles. Thus, traditionally, unless the conditionthat the patient was experiencing was considered anything but“superficial,” and not near eloquent structures of the brain, have beenconsidered challenging to access, simply because of the biological costof surgical access to the abnormality are considered too high and may bejust as damaging as letting the condition take its course. Similarly,tissue abnormalities such as tumors, cysts and fibrous membrane growthswhich manifest within the intraventricular space of the brain areconsidered challenging to safely access and often inoperable, due totheir size or location within the brain.

In order to assist in diagnosis and subsequent treatment of braindisorders, clear, accurate imaging of brain tissue through the skull isrequired. In recent years significant advances have been made in imagingtechnology, including stereotactic X-ray imaging, Computerized AxialTomography (CAT), Computerized Tomographic Angiography (CTA), PositionEmission Tomography (PET) and Magnetic Resonance Imaging (MRI),Diffusion Tensor Imaging (DTI) and Navigation systems (instrumentposition tracking systems). These imaging devices and techniques permitthe surgeon to observe conditions within the brain in a non-invasivemanner without opening the skull, as well as provide a map of criticalstructures surrounding an area of interest, including structures such asblood vessels, membranes, tumor margins, cranial nerves, including fibertracts and fascicles. If an abnormality is identified through the use ofone or more imaging modalities and/or techniques, it may be necessary ordesirable to biopsy or remove the abnormality.

Once a course of action has been determined based upon one or moreimaging techniques, a surgical treatment may be necessary or desired. Inorder to operate surgically on the brain, access must be obtainedthrough the skull and delicate brain tissue containing blood vessels andnerves that can be adversely affected by even slight disturbances.Therefore, great care must be taken in operating on the brain so as notto disturb delicate blood vessels and nerves to prevent adverseconsequences resulting from a surgical intervention.

Traditionally, accessing areas of the brain where abnormalities or otherconditions which manifest in deeper spaces within the brain has meant aneed for a surgery that creates a highly invasive approach, if anyapproach at all is feasible. In some instances, in order to obtainaccess to target tissue, a substantial portion of the skull is removedand entire sections of the brain are retracted or removed to obtainaccess. For example, surgical brain retractors are used to pull apart orspread delicate brain tissue, which can leave pressure marks fromlateral edges of the retractor. In some instances, a complication knownas “retraction injury” may occur due to use of brain retractors. Ofcourse, such techniques are not appropriate for all situations, and notall patients are able to tolerate and recover from such invasivetechniques.

It is also known to access certain portions of the brain by creating aburr hole craniotomy, but only limited surgical techniques may beperformed through such smaller openings. In addition, some techniqueshave been developed to enter through the nasal passages, opening anaccess hole through the occipital bone to remove tumors located, forexample, in the area of the pituitary. These approaches are referred toas Expanded Endonasal Approaches (EEA) and were pioneered by one of theinventors of this disclosure.

A significant advance in brain surgery is stereotactic surgery involvinga stereotactic frame correlated to stereotactic X-ray images to guide anavigational system probe or other surgical instrument through anopening formed in the skull through brain tissue to a target lesion orother body. A related advance is frameless image guidance (IGS—Imageguided surgery), in which an image of the navigation probe or navigatedsurgical instrument is superimposed on a pre-operative image todemonstrate the location of the instrument to the surgeon and trajectoryof further movement of the probe or instrument while in the surgicalsuite.

In recent years, surgical access systems have been developed to provideaccess to previously difficult to access areas. One such prior artsystem is shown in FIGS. 1A-1C. System 10 includes a retractor 20 and anintroducer 40. Introducer 40 includes a cone-shaped distal end 42 withan opening 52 therein (best seen in FIG. 1C). The cone-shaped distal endis configured to be a generally blunt, flat surface. With introducer 40positioned within retractor 10, system 10 is inserted into brain tissue,thereby pushing brain tissue away while providing access to an area ofinterest. Once system 10 is delivered to the area of interest, retractor10 is rigidly fixed in position. More specifically, retractor 10 isfixed in space with the use of a standard or conventional neurosurgicalfixation device. Once, retractor 10 is fixed in place, introducer 40 isthen removed from retractor 10, while leaving retractor 10 in its fixedplace, thereby creating a pathway through the brain tissue.

While access system 10 may provide a manner to access certain braintissue, the blunt shaped distal end of can actually cause transient oreven permanent deformation and trauma of delicate tissue structureswhich can manifest itself in temporary or permanent neurologicaldeficits after surgical cytoreduction due to damage of blood vessels,cranial nerves, fiber tracts and fascicles. Opening 52 may cause coringof tissue, also leading to damage of the tissues and structures asintroducer 40 is pushed through tissue. Further, by rigidly fixing theplacement of retractor 10, manipulation of retractor 10 is impeded andrequires constant attention by loosening and retightening to re-positionfor even micro-movement of the retractor 10, thereby lengtheningprocedure time.

Another issue that needs to be addressed is visibility. Typically whenemploying an access system in a surgical procedure, it is often likeoperating in a poorly lit tunnel. To provide illumination, it is knownto place a light source within the introducer sheath, such as anendoscope. However, when using an endoscope, the light source takes up asignificant amount of working space within the introducer sheath, thusreducing the functional working area for other instruments, as well asminimizing the ability to move other instruments within the surgicalsite.

Alternatively, light must be delivered from a remote or externallocation, such as a microscope or exoscope. However, in the case ofmicroscopes and exoscopes, the external light source is often blocked bythe surgeon and/or instruments in the surgical field. At a minimum, theeffectiveness is greatly diminished at the distal end of the introducersheath where the actual surgical work and/or treatment is occurring, andwhere effective visualization is needed the most.

Notwithstanding the foregoing advances in imaging technology and bothframe and frameless stereotactic image guidance techniques, thereremains a need for improved surgical techniques and apparatus foroperating on brain tissue.

There also exists a need for improved and effective treatment regimensand options. Traditionally, once a disease or medical condition isidentified, patients are treated with a “one-size” fits all approachwhich typically includes a generic protocol regimen which is deliveredsystemically, thereby affecting the entire body unnecessarily. Forexample for certain cancers a heavy chemotherapy protocol regimen isdelivered systemically and is designed to provide a balance betweenenough poison to kill the cancerous cells and tissue without killing thehealthy tissues. High doses and multiple exposures to radiation are alsotypically used and delivered by products such as the Gamma Knife andCyber Knife. However, such treatment regimens are often nothing morethan a series of “experiments” on the patient in an effort to find aneffective treatment plan. Accordingly the patient must be monitored toascertain the effectiveness of the generic therapeutic regimen andcontinuous modification and tweaking of the treatment regime isperformed based upon the positive or negative results of each of theprevious successes or failures while attempting to balance the sparingof healthy tissues and poisoning effect of the treatment process on thewhole patient. Such a treatment regime effectively results in thepatient being a guinea pig until a treatment regime is achieved tomanage the disease or as in most cases of brain cancers the patient diesfrom the disease. Unfortunately, in the case of brain cancers, thepatient often succumbs to the disease before an effective treatmentregime is achieved. Regardless of these heroic clinical efforts that arevery biologically caustic to the patient, rarely are any of the currenttreatment paradigm curative. In fact, since patients diagnosed withbrain cancers often do not typically live beyond 9-14 months afterinitial diagnosis of the disease, long term clinical implications ofwhole body chemo or target directed radiation therapy are unknown inthese patients and may be detrimental if the patient lived long enoughfor the true impact to be understood.

In addition, most current therapeutic treatment regimens that involvedelivering therapy regimens systemically and depend on overcoming thelimitations of delivery through the bloodstream which include thefiltering effects of the liver and kidneys. However, the blood-brainbarrier, which serves to separate circulating blood from the brainextracellular fluid in the central nervous system (CNS), createsadditional challenges to delivering therapeutic agents to specificregions of the brain through the bloodstream. More specifically, theblood-brain barrier actually functions in a neuroprotective role. Thusthe blood-brain barrier actually impedes delivery of therapeutic agentsto the brain. Therapeutic molecules that might otherwise be effective intherapy are typically larger molecules than the blood brain barriersieve and for this reason do not cross the blood brain barrier inadequate amounts. In addition to the blood brain barrier, othermechanisms exist within the body to filter out foreign materials andchemicals such as the liver and the kidneys. These filtering createadditional challenges for the delivery of appropriate concentrations oftherapeutics the intended site of treatment for central nervous systemdiseases and other hormonally based abnormality/diseases that call forregulation of bodily functions and activities as well as painmodulation.

To overcome the treatment issues associated with the blood brainbarrier, mechanical opening of the blood brain barrier has beenproposed, which may complicate the procedure. In addition, use ofsmaller particles (i.e., nano-particles) have been proposed, whereby thesmaller particles are sized to pass through the blood brain barrier,then are attempted to be recombined to form a larger and more effectivetherapeutic molecule. However, in some instances, the smaller particlesfail to recombine in therapeutic levels. Other means to breach the bloodbrain barrier include delivering chemicals designed to temporarily openup the blood brain barrier to allow for a period of time that largermolecules at therapeutic levels may pass across it. Once across theblood brain barrier, the therapeutic treatment must still get to thediseased tissue, resulting in poisoning healthy tissue, as well asdiseased tissue.

Additionally, it is believed that since certain diseases of the brain,such as cancers, often behave like a virus or bacteria in that once theyare treated, but not eradicated by the therapeutic regimen delivered tothem, they may morph and become resistant to the treatment that had beenpreviously delivered to them. These residual unaffected abnormal cellsmay mutate into a strain of cells that become resistant to the therapythat was delivered to them previously. In cases of functional diseases,and/or other abnormalities, the effectiveness of treatment on braintissue may be difficult to evaluate.

Accordingly, there exists a need for effective treatment regimes thatovercomes the challenges created by systemic delivery of therapies so asto overcome the filtering effects of the kidneys, liver and blood brainbarrier, while providing targeted treatment to the diseased tissue,dysfunctional tissue, or brain abnormality rather than healthy tissue.There also exists a need for a method of evaluating effectiveness ofpreviously delivered treatment, as well as providing for subsequenttherapy/treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the present disclosure will now be described ingreater detail with reference to the attached figures, in which:

FIGS. 1A-1C illustrate a prior art surgical access system.

FIG. 2 is a perspective cross-sectional view of an exemplary arrangementof a surgical access assembly.

FIG. 3 is a perspective view of an outer sheath of the surgical accessassembly of FIG. 2 .

FIG. 4A is a side elevational view of the outer sheath of FIG. 3 .

FIG. 4B is an enlarged cross-sectional view of a portion of the distalend of the outer sheath of FIG. 4A.

FIG. 4C is an enlarged cross-sectional view of a portion of analternative embodiment of the distal end of the outer sheath of FIG. 4A.

FIG. 5 is an end view of outer sheath of FIG. 3 .

FIG. 6A is an elevational view of an alternative embodiment of an outersheath.

FIG. 6B is an end view of the outer sheath of FIG. 6A.

FIG. 7A is a perspective view of an obturator assembly of the surgicalaccess assembly of FIG. 2 .

FIG. 7B is an enlarged view of an end face of the obturator assemblytaken from area 7B of FIG. 7A.

FIG. 8A is a top view of the obturator assembly of FIG. 7A.

FIG. 8B is an enlarged view of a distal end of the obturator assemblytaken from area 8B of FIG. 8A.

FIG. 8C is an alternative embodiment of the distal end of the obturatorassembly taken from area 8B of FIG. 8A.

FIG. 8D is an alternative embodiment of the distal end of the obturatorassembly taken from area 8B of FIG. 8A.

FIG. 9A is a side elevational view of the obturator assembly of FIG. 7A.

FIG. 9B is an enlarged view of a portion of the obturator assembly takenfrom area 9B of FIG. 9A.

FIG. 10 is an end view of the obturator assembly of FIG. 7A.

FIG. 11A is a perspective view of an illuminating ring that operativelyconnects to an outer sheath of the surgical access assembly.

FIG. 11B is a side view of the illuminating ring of FIG. 11A.

FIG. 11C is a top view of the illuminating ring of FIG. 11A.

FIG. 11D is a bottom plan view of the illuminating ring of FIG. 11A.

FIG. 11E is a cross-sectional view of an exemplary arrangement of alighting arrangement for the illuminating of FIG. 11A.

FIG. 11F is a plan view of a circuit board for use with the illuminatingring of 11A.

FIG. 11G is an exemplary electrical schematic for use with theilluminating ring of FIG. 11A.

FIG. 11H is a top plan view of an alternative arrangement of theilluminating ring of FIG. 11A.

FIG. 11I is a bottom plan view of the illuminating ring of FIG. 11H.

FIG. 12 illustrates the illuminating ring of FIG. 11A assembled to anexemplary embodiment of the outer sheath.

FIG. 13 is a flow chart illustrating a process flow using the surgicalaccess assembly.

FIG. 14A-14B are images of a brain illustrating an area of interest,taken using an imaging modality.

FIG. 15 is an image taken of the brain shown in FIGS. 14A-14B,illustrating various critical structures, such as fiber tracts andfascicles of the brain.

FIG. 16A is an alternative embodiment of an obturator with an imagingdevice operatively connected thereto.

FIG. 16B is a partially exploded view of an enlarged cross-sectionalview of the proximal end of the obturator and post.

FIG. 16C is an alternative arrangement of a coil sensor for use with anobturator.

FIG. 16D is an end view of the coil sensor mounted on the post of FIG.16C.

FIG. 17A is an elevational view of the surgical access system, while theobturator is being withdrawn from the outer sheath.

FIG. 17B is an elevational view of the surgical access system with theouter sheath in place within the brain.

FIG. 18 is a perspective view of an exemplary surgical device used forcytoreduction.

FIG. 19A is an elevational view of an exemplary manipulation member.

FIG. 19B is an elevational view of an alternative manipulation member.

FIG. 19C is a top view of the outer sheath operatively connected to afirst exemplary arrangement of a holding arrangement therefore.

FIG. 19D is an elevational view of the outer sheath and holdingarrangement of FIG. 19C.

FIG. 19E is a top view of the outer sheath operatively connected to asecond exemplary arrangement of a holding arrangement therefore.

FIG. 19F is an elevational view of the outer sheath and holdingarrangement of FIG. 19C.

FIG. 19G is a side elevational view of the outer sheath operativelyconnected to a third exemplary arrangement of a holding arrangementtherefore and an exoscope.

FIG. 19H is a perspective elevational view of the outer sheath, holdingarrangement and exoscope of FIG. 19G.

FIG. 19I is an enlarged perspective view of a top portion of the outersheath, illustrating the connection of the holding arrangement to theouter sheath.

FIG. 19J is a top view of the top portion of the outer sheath,illustrating an alternative connection of the holding arrangement ofFIGS. 19G-H.

FIG. 20 is a partial perspective view of an exemplary delivery sleevethat may be used with a surgical device.

FIG. 21A is an exemplary arrangement for a therapy delivery device.

FIG. 21B is an alternative arrangement of the therapy delivery device ofFIG. 21A.

FIG. 22 is a flow chart illustrating a process flow for follow-uptherapy whereby the surgical access assembly may be employed.

DETAILED DESCRIPTION

Referring now to the discussion that follows and also to the drawings,illustrative approaches to the disclosed assemblies and methods areshown in detail. Although the drawings represent some possibleapproaches, the drawings are not necessarily to scale and certainfeatures may be exaggerated, removed, or partially sectioned to betterillustrate and explain the present disclosure. Further, the descriptionsset forth herein are not intended to be exhaustive or otherwise limit orrestrict the claims to the precise forms and configurations shown in thedrawings and disclosed in the following detailed description.

Described herein is surgical access assembly, various components for usein same, and a method of using the surgical access assembly. Thecomponents disclosed herein provide surgeons with an enhanced ability tominimize trauma to the patient, while providing efficient improvedminimally invasive surgical techniques, such as, for example, duringintracranial surgical techniques. The components disclosed herein mayfurther be used for application of targeted and effective treatmentregimens.

Referring to FIG. 2 , a perspective cross-sectional view of a surgicalaccess assembly 100 is shown. In one exemplary arrangement, surgicalaccess assembly 100 comprises a hollow outer sheath 102 and aselectively removable obturator 104. As best seen in FIG. 2 , obturator104 is configured with a length that is longer than a length of outersheath 102 such that a distal end 106 of obturator 104 protrudes apredetermined distance from a distal end 108 outer sheath 102, as willbe discussed below in greater detail.

A locking member 110 may also be provided. Locking member 100 isconfigured to operatively retain a separate navigation member 112 (shownin phantom) within obturator 104, as will be discussed in greater detailbelow. A retaining member 114 may be secured within a portion ofobturator 104 to prevent locking member 110 from being completelydisengaged from obturator 104.

Referring now to FIGS. 3-5 , outer sheath 102 will be described ingreater detail. Outer sheath 102 is defined by distal end 108 and aproximal end 116 and includes a generally hollow body portion 118 and agrip portion 120. In one exemplary arrangement, grip portion 120 isconfigured as a ring, as illustrated in the drawings. However, it isunderstood that grip portion 120 need not be configured as a ring. Forease of explanation, grip portion 120 will be referred to hereinafter asgrip ring 120. Grip ring 120 is fixedly secured to body portion 118 atproximal end 116. In one exemplary arrangement, body portion 118 isconstructed of a clear biocompatible material that permits viewing ofnormal tissue, abnormal tissue, as well as critical structures that aredisposed outside of body portion 118 when outer sheath 102 is disposedwithin such tissue. In one exemplary arrangement, outer sheath 102 isconstructed of polycarbonate, though other biocompatible materials maybe employed, including resins.

In one exemplary configuration, an imaging mechanism may be incorporatedinto outer sheath 102 that would permit visualization of tumors,vessels, fiber tracks, fascicles and even healthy tissue, in real-time.Indeed, as will be explained in further detail below, the imagingmechanism will enable physiological functional imaging to provideinformation about the characteristics of the cortical fiber tracks to bevisible, thereby enabling a user to separate and park such fibers oneither side of outer sheath 102 rather than cutting, stretching andpotentially damaging such fibers while gaining access to a desiredlocation within the brain. Further, as will be explained in furtherdetail below, the imaging mechanism may also enable the surgeon to havereal-time information about the fiber tract and fascicle location, afterplacement of outer sheath 104, and during abnormality resectionprocedure therethrough. In addition to white matter tract imaging,mapping of the characteristics of the cerebral blood flow may beobtained.

In one exemplary embodiment, the imaging mechanism may be an ultrasoundprobe incorporated into outer sheath 102. For example, outer sheath 102may be provided with one or more channels within the wall that definesouter sheath 102 that are configured with one or more small diameterultrasound probes. In another arrangement, a single ultrasound probethat is configured to be received within outer sheath 102 may beprovided. In yet another embodiment, a low field MRI probe may beselectively placed in outer sheath 102 to provide enhanced imaging. Inyet another embodiment a low field MRI imaging coil may be molded intoor bonded into outer sheath 102. In still another exemplary arrangement,the probe may be an optical coherent tomography (OCT) imaging orspectroscopy.

In another exemplary arrangement, as will be explained in further detailbelow, outer sheath 102 may also be (or alternatively be) providednavigational capabilities that permit a user to “read” the location ofouter shaft 102 after placement at an area of interest, as well asupdate the location of outer sheath 102 during a procedure. In oneexemplary arrangement, an RFID chip or sensor that is configured to betracked by a navigation system, may be incorporated into outer sheath102. For example, an RFID chip or sensor may be permanently attached toouter sheath 102, for example, by impregnating or molding the RFID chipor sensor therein. In other exemplary arrangements, a temporary sensoror chip may be incorporated into or attached to outer sheath 102. Forexample, outer sheath 102 may be provided with one or more channelswithin the wall that defines outer sheath 102. An RFID chip and/orsensor may be positioned within the channels.

Distal end 108 of outer sheath 102 may be configured with a taperedportion 130 that extends towards a center axis A-A of outer sheath 102to a distal edge 132 that surrounds an opening 134 in distal end 108 ofouter sheath 102. Tapered portion 130 serves to ease the transitionbetween outer sheath 102 and a distal tip portion 172, without drag,trauma or coring of tissue from a diameter that defines a body portion168 of obturator 104 to a diameter that defines body portion 118 ofouter sheath 102. In one exemplary configuration, distal end 108 may beconfigured with a radius or other configuration so as to create asmooth/atraumatic transition of the brain tissue when surgical accessassembly 100 is inserted into the brain.

For example, as best seen in FIG. 4B, distal edge 132 is configured soas to be non-sharpened and radiused. In one exemplary arrangement,distal edge 132 is configured as a 0.3 mm diameter radiused rim. Taperedportion 130 and radiused distal tip 132 cooperates with obturator 104 toatraumatically move tissue, as well as various structures within thebrain, including white matter, away from outer sheath 102 withoutcutting tissue or such structures. Indeed, unlike prior art devices thatinclude either a blunt tip distal end or a tapered leading edge such asthat shown in FIG. 1C, radiused distal tip 132 cooperates with taperedportion 130 and obturator 104 to prevent bruising and damage to varioustissue. More specifically, this configuration facilitates entry of outersheath 102 into delicate tissue, but without cutting such delicatetissue. Insertion of surgical access assembly 100 will be explained infurther detail below.

Body portion 118 may further be provided with a plurality of spacedapart indicators 136. Indicators 136 generally extend about thecircumference of body portion 118 and each may further incorporate asecondary indicator 138 that visually illustrates a predeterminedlocation on body portion 118, as shown in FIG. 3 . While FIG. 3illustrates four indicators 136, it is understood that body portion 118may be provided in a variety of lengths and that any number ofindicators 136 may be provided. Body portion 118 may also be providedwith a longitudinal indicator 140. More specifically, as best seen inFIG. 4A, longitudinal indicator 140 extends from proximal end 116 todistal end 108. Indicators 136, 138 and 140 may be printed onto eitheran internal or external surface of body portion 118 with an imagingvisible ink such as, for example ink containing fluro-deoxyglucose(FDG), Technicium 99, Gadolinium, titanium dust, barium sulfate, acombination of the above or other suitable imaging material. Indicators136 and 138 provide a reference point for the operator of system 100, asstructures may be visible through body portion 118. Indicator 136, 138and 140 may also be configured to be visible under MRI, CT, PET, or anyother suitable imaging modality to enable easy identification of areasof interest. In one alternative embodiment, indicators 136, 138 and/or140 may be etched or printed onto body portion 118, either on theinternal or external surface of body portion 118.

Details of grip ring 120 are best seen in FIG. 5 . Grip ring 120 isgenerally configured as a flange member 142 defined by an outerperiphery 144 and an inner opening 146. Inner opening 146 may be sizedto generally correspond to the diameter of a lumen 148 defined by bodyportion 118. Outer periphery 144 is sized to have a diameter that islarger than lumen 148 of body portion 26. Flange member 142 may furtherbe provided with one or more small openings 150 that are disposedtherein. In one exemplary arrangement, a plurality of small openings 150are provided that are spaced generally equi-distantly about inneropening 146. Small openings 150 will be described in further detailbelow. Outer periphery 144 may further be provided with a texturedsurface 152 to provide for ease of gripping outer sheath 102. Forexample, in one exemplary arrangement, textured surface 152 comprises aplurality of alternating ridges 154 and grooves 156. However, it isunderstood that other textured surfaces may be employed.

Disposed on a proximal end surface 158 of flange member 142, analignment feature 160 may be employed. Alignment feature 160 is used toindicate the location of longitudinal indicator 140 when outer sheath102 is positioned within the brain. Alignment feature 160 will bediscussed below in greater detail.

An alternative embodiment of outer sheath 202 is shown in FIGS. 6A-6B.Outer sheath 202 is similar to outer sheath 102 in that it is defined bya distal end 208, a proximal end 216 and a body portion 218. A distaledge 232 is generally configured to be similar as distal tip 132. A gripring 220 is fixedly secured to body portion 218.

Grip ring 220 also includes a textured surface 252. Grip ring 220further includes a locating member 262. Locating member 262 isconfigured to operatively connect an illumination ring (best seen inFIG. 11A) 300 to outer sheath 102. As may be seen, in one exemplaryconfiguration, locating member 262 extends outwardly from outerperiphery 244 of grip ring 220. Locating member 262 may also serve as analignment feature for indicating the location of longitudinal indicator240. Alternatively, a separate alignment feature 260 may be provided.For example, in FIG. 6B, alignment feature 260 is positioned adjacentlocating member 262.

Body portion 218 may also be provided with indicators 34, 36, and 38 toassist in locating outer sheath 202 in operation. However, in anotheralternative arrangement, body portion 218 may be provided withindicators 264 that produce a signal void or minimal artifact undercertain imaging modalities. In one specific arrangement, indicators 264may be configured as small holes that are spaced apart at predetermineddistances, as shown in FIG. 6A. In yet another alternative arrangement,indicators 264 may be configured as non-through divots. In still afurther alternative arrangement, indicators 264 may be configured as alongitudinal groove (not shown) on either the internal or externalsurface of body portion 218.

Referring to FIGS. 7-10 , obturator 104 will now be described. Obturator104 is defined by distal end 106, a proximal end 166, a body portion 168and a handle portion 170. Distal end 106 is configured with a generallyconical shaped distal tip portion 172 that tapers to a tip member 174 toprovide atraumatic dilation of tissue. In one exemplary arrangement, tipportion 172 tapers toward a closed tip member 174 so as to preventcoring of tissue as obturator 104 is inserted into the brain.

There are a number of variables that play the selection of the angle αthat defines the taper of tip portion 172. These variables include thesize of an outer diameter D1 of obturator 104, the desired length thatdistal tip portion 172 extends from body portion 168, and the desiredoffset for a distal tip of navigation member 112 and tip member 174.More specifically, it is contemplated that surgical access assembly 100will be provided as part of a kit that may include multiple sized outersheaths 102 and obturators 104, to provide the surgeon with a choice ofdifferent diameter sizes and lengths so as to provide flexibility foraccessing areas of interest within the brain. However, to insure thatthe distal tip 174 is determinable regardless of which size diameter D1of obturator 104 is used, taper angle α may be selectively adjusted. Forembodiments that utilize navigation member 112 that positions a distalend thereof at a set position within obturator 104 (as will be explainedin further detail below), to maintain an identical offset length betweenthe distal end of navigation member 112 and distal tip 174 in differentdiameter D1 sized obturators 104, taper angle α will need to beincreased, as diameter D1 increases.

For example, if diameter D1 of obturator 104 is 13.5 mm, an exemplaryangle α may be 45.5° to provide effective atraumatic dilation, as wellas a determinable distal tip 174 location. However, if diameter D1 ofobturator 104 is 15.5 mm, an exemplary angle α′ may be 52.8°.

As best seen in FIG. 8B, distal tip 174 is configured to be radiusedsuch that tip member 174 is rounded, and neither blunt, nor sharp. Morespecifically, tip member 174 is configured so as not to have any flatportions which during insertion can stretch or even tear the delicatetissues such as the vessels, fiber tracts and fascicles found in thebrain. Further, because tip member 174 is closed, damage of suchdelicate tissues and fascicles are also avoided. In one exemplaryembodiment, tip member 174 is configured with a 0.5 mm radius. As willbe explained in further detail below, the configuration of tip member174 is designed to gently displace and move the tissue into which it isinserted; i.e., atraumatically dilate the tissue to allow forintroduction in to an intra-fascilar and para-fascilar manner, asopposed to cutting tissue as surgical access assembly 100 is insertedinto the tissue.

Handle portion 170 is positioned at proximal end 166 of obturator 104.As best seen in FIGS. 7B, 8A and 9A, handle portion 170 comprises a stopmember 176 and a grip member 178. Stop member 176 is positioned distallyof grip member 178 and, as best seen in FIG. 8A, is configured to have awidth W1 that is greater than a diameter D1 of body portion 168, as wellas a diameter D2 of outer sheath 102 (shown in FIG. 4A). Grip member 178is configured with a width W2 that is greater than the width W1 of stopmember 176, thereby providing a step-like configuration. Stop member 176further defines an engagement surface 177 that is axially spaced from adistal surface 179 of grip member 178.

In one exemplary arrangement, handle portion 170 is configured with agenerally planar surface 180, as best seen in FIGS. 7A-7B and FIG. 10 .Planar surface 180 is configured with a receiving aperture 182 that isconfigured to receive locking member 110. In one exemplary arrangement,receiving aperture 182 is threaded. As best seen in FIGS. 2, 7B, and 8A,disposed within receiving aperture 182 is an engagement opening 184.Engagement opening 184 is in communication with a channel 186 (seen inphantom in FIGS. 8A and 9A) that extends at least partially thoroughhandle portion 170. After locking member 110 is at least partiallyengaged within receiving aperture 182, retaining member 114 (FIG. 2 ) ispositioned within channel 186. Because engagement opening 184 opens intoreceiving aperture 182, a portion of retaining member 114 extends acrossa portion of receiving aperture 182 such that locking member 110 isprevented from being entirely withdrawn from receiving aperture 182. Forexample, locking member 110 is illustrated as having threads thatcooperate with corresponding internal threads in receiving aperture 182.Retaining member 114 is positioned within channel 186 so as to extendabove the threads of locking member 110 such as locking member 110 isbeing removed from receiving aperture 182, threads come into contactretaining member 114, thereby preventing complete removal of lockingmember 110 from handle portion 170.

An access opening 188 is formed through proximal end 166. Access opening188 extends through handle portion 170. In one exemplary arrangement,access opening 188 may be provided with an inwardly extending chamfer189 that tapers toward access opening 188. Chamfer 189 provides aself-directing feature for inserting navigation member 112 into accessopening 188. Access opening 188 is in communication with a first channelsegment 191 that extends through handle portion 170 and into bodyportion 168.

As seen in FIG. 8D, obturator 104 may further be configured to receive aviewing member 167 operatively connected thereto. More specifically,conical tip portion 172 may be configured with one or more viewingwindows 169 that are oriented to be flush with the surface of conicaltip portion 172. Viewing windows 169 are in communication with a viewingmember channel 171 that may selectively receive a viewing member suchas, for example, a fiber optic cable or an ultrasound probe. The viewingmember may be in addition to the use of navigation member, or in placethereof. The viewing member permits the surgeon to observe, in real-time(i.e., during insertion), surrounding tissue and eloquent tissuestructures so as to minimize trauma during insertion.

Body portion 168 extends between distal end 106 and proximal end 166.Body portion 168 includes one or more elongated void areas 190. Voidareas 190 serve to reduce weight of obturator 104, thereby makingobturator 104 easier to manipulate during surgical procedures. Voidareas 190 also facilitate sterilization of obturator 104 by moistureretention within body portion 168 of obturator 104. Further, void areas190 also provide venting, thereby preventing a vacuum from beinggenerated as obturator 104 is being withdrawn from outer sheath 102during operation.

Void areas 190 are separated by web portions 192 that extend axiallythrough a portion of the length of body portion 168. Disposed on webportions 192 of body portion 168 are one or more indicators 194.Indicators 194 may include spaced apart hash marks (designated as 194A)that cooperate with an imaging modality to provide information, inreal-time, concerning the location of obturator 104 relative to varioustissue, critical structures, and fascicles within the brain, whileobturator 104 is positioned within tissue. Indicators 194 also assistwith providing information to regarding the relative positions betweenobturator 104 and outer sheath 102. Indicators 194 produce a signal voidor minimal artifact under certain imaging modalities.

Body portion 168 may further include one or more cross webs 196. Crosswebs 196 are oriented transverse to web portions 192 and connect webportions 192 together. In one exemplary arrangement, body portion 168includes at least one cross web 196 that operatively defines the outerdiameter D2 of body portion 168. Diameter D2 is sized to fit withinlumen 148 of outer sheath 102 such that obturator 104 and outer sheath102 may be selectively slid relative to one another. However, diameterD2 is also sized to minimize or even eliminate any gaps between an innersurface of outer sheath 102 and an outer surface of obturator 104. Inthe exemplary arrangement shown in FIG. 7-9 , three cross webs 196A,196B and 196C are provided. A first cross web 196A is connected todistal tip portion 172, while second cross web 196B is spaced proximallyfrom first cross web 196A and separated by a void area 193. Third crossweb 196C is separated from second cross web 196B by void areas 192 andis positioned distal from first stop member 176 of handle portion 170.Cross webs 196 serve to provide for structural integrity of obturator104, as well as improved rigidity.

In one exemplary arrangement, one or more of cross webs 196 may furtherbe provided with an annular compensating protuberance 197 to accommodatefor slight manufacturing variations of the diameter of lumen 148 ofouter sheath 102. For example, as it is contemplated that outer sheath102 may be a component that is molded from a resin, a process which mayproduce such slight manufacturing variations. Compensating protuburance197 extends slightly radially outwardly from an outer surface ofobturator 104 and cooperates with lumen 148 of outer sheath 102 tocreate a friction fit between the outer surface of obturator 104 andlumen 148, due to the slight flexibility of the resin of outer sheath102. Use of compensating protuberance 197 thereby reducing the need formaintaining a high dimensional tolerance of outer sheath 102 inproduction.

In one embodiment, cross web 196B is provided with a second channelsegment 198 (shown in phantom) that extends there through. Secondchannel segment 198 is axially aligned with first channel segment 191and is configured to selectively receive navigation member 112. In oneexemplary arrangement, disposed in first cross web 196A is an inwardlyextending depression 199, as best seen in FIG. 9B. Depression 199 isconfigured in such a manner so as to align a distal tip of navigationmember 112 with distal end 108 of outer sheath 102, when outer sheath102 is assembled to obturator 104.

Referring to FIGS. 11A-11F, details of an optional illuminating ring 300will now be described. Illuminating ring 300 is generally defined by atop surface portion 302, a wall member 304. A circuit board 306 may alsobe provided. Top surface 302 includes at least one access opening 308therethrough that is configured to receive one or more surgicalinstruments, as will be described below in further detail. Additionalsmall openings 309 may be provided in top surface 302. One or more ofsmall openings 309 are configured to be aligned with small openings 150disposed on flange member 142. Wall member 304 extends from top surface302 so as to create an open cavity 310 within illuminating ring 300. Anouter surface of wall member 304 may be textured (not shown), similar togrip ring 120.

One or more light elements 312 that are supported by a portion ofilluminating ring 300. In one embodiment, shown in FIG. 11E, lights 312are fixedly mounted to top surface 304 so as to face inwardly towardopen cavity 310, adjacent access opening 308. Each light 312 iselectrically connected to a remote power source (not shown) by wires314. In one exemplary arrangement, wires 314 may be retained withinchannels formed in top surface 302 around access opening 308.

In an alternative arrangement (FIG. 11F), lights 312 may be incorporatedin a circuit board 306. Circuit board 306 is configured with an accessopening 316 that may be aligned with access opening 308 formed in topsurface 302. Further, circuit board 306 is also sized to be positionedwithin open cavity 310, and fixed thereto. In other words, in onearrangement, circuit board 306 is sized to have an outer diameter thatis smaller than an inner diameter defined by wall member 304. A wallopening 318 may be formed through a portion of either top surface 302 orwall member 304 to provide access for wires 320 to electrically connectcircuit board 306 to a power source. An example of wall opening 318 maybe seen in FIGS. 11B, 11D, and 11F. Circuit board 306 may be configuredsuch that there is a constant output of light when illuminating ring 300is turned on so that there is a steady state.

An exemplary circuit design 321 is depicted in FIG. 11G for circuitboard 306. In the exemplary configuration, circuit design 321 isconfigured to prevent flickering of lights 312 and/or prevent operationof less than all of the lights 312 during use of illuminating ring 300.More specifically, circuit design 321 is configured such that if onelight 312 burns out, or if batteries that supply power to circuit getlow, illuminating ring 300 will simply shut off and a replacementbattery pack (not shown) may be used.

In one exemplary arrangement, lights 312 are LED lights, although otherlight devices may be utilized. LED lights do not contributesignificantly to the weight of surgical access assembly 100, and alsodissipates a non-clinical significant amount of heat. Moreover, LEDlights can emit different combinations of colors/frequencies of lightthat may be incorporated to illuminating ring 300, to provide improvedvisualization of fluorescing dyes which allow for the differentiation oftissues.

Use of LED lights also allow for an endoscope to be used with surgicalaccess assembly 100, but without an accompanying fiber-optic lightsource. This arrangement significantly reduces a required overalloutside diameter of the endoscope, which improves the working spacewithin lumen 148 of outer sheath 102. More specifically, lumen 148 ofouter sheath 102 has more available working space, thereby providingincreased simultaneous use of multiple instrumentation, as well asimproved visualization. Further, because traditional endoscope devicesmust be attached to a supporting structure that is fixed to anintroducer cannula, the weight of such an assembly tends to pull on theintroducer cannula, in one direction. This action can compromise theplacement of the introducer cannula during the procedure and/or causetrauma to brain tissue. Thus, by incorporating illuminating ring 300 toouter sheath, such potential disadvantages may be avoided.

While illuminating ring 300 may be secured to grip ring 120 of outersheath 102 in any suitable manner, in one exemplary arrangement,illuminating ring 300 is provided with a selective locking arrangementto selectively fix illuminating ring 300 to grip ring 120. In oneexemplary arrangement, wall member 304 is provided with a lockingchannel 322, best seen in FIG. 11B. Locking channel 322 comprises wallopening 318 and that opens into a first channel segment 324, and asecond channel segment 326 that is in communication with first channelsegment 324. Wall opening 318 extends from a bottom surface 328 of wallmember 304. Second channel segment 326 is spaced upwardly from bottomsurface 328 of wall member 304 and is oriented at an angle from firstchannel segment 324. In one exemplary arrangement, second channelsegment 326 is oriented 90° from first channel segment 324.

Locking channel 322 cooperates with locating member 262 to selectivelysecure illuminating ring 300 to grip ring 120. More specifically,illuminating ring 300 is pushed down over grip ring 120 with locatingmember 262 entering wall opening 318. As illuminating ring 300 is pusheddownwardly, locating member 262 travels through first channel segment324. Once locating member 262 contacts a terminal end 330 of firstchannel segment 324, illuminating ring 300 is rotated relative to outersheath 102 such that locating member 262 moves into second channelsegment 326, thereby selectively locking illuminating ring 300 to outersheath 102, as shown in FIG. 12 . Once connected, illuminating ring 300thereby provides a hands-free light source to illuminate lumen 148 ofouter sheath 102.

In one exemplary arrangement, certain segments of outer sheath 102 maybe frosted so as to reflect light to increase visualization within outersheath 102. For example, tapered portion 130 may be frosted. Similarly,the top of grip ring 120 may also be frosted.

Referring to FIGS. 11H-I, an alternative arrangement of illuminatingring 350 is shown. Illuminating ring 350 is similar to illuminating ring300 and common elements, such as top surface 302, wall member 304,access opening 308, open cavity 310, small openings 309, and wallopening 318, are also shown in FIGS. 11H-I. The embodiment shown inFIGS. 11H-I further includes outwardly extending flange members 352. Inone arrangement, flange members 352 are integrally formed with the outerperiphery of illuminating ring 350. While the depicted embodimentincludes three flange members 352 spaced equi-distantly about aperiphery of a wall member of illuminating ring 300, it is understoodthat any number of flange members 352 may be provided. Further, flangemembers 352 may be arranged about the periphery in any arrangement.

Flange members 352 support sensors 354 (see FIG. 11I) or reflectiveballs that serve as position indicators. More specifically, sensors 354are configurable to cooperate with a navigation system (to be explainedin further detail below), to indicate the location of outer sheath 102after insertion into an area of interest, once illuminating ring 300 isconnected to outer sheath 102. In one arrangement, sensors 354 may bemolded into or bonded onto flange members 352. In another arrangement,sensors 354 may be temporarily attached to flange members 352. Forexample, flange members 352 may each include a groove into which asensor may be positioned, and a retaining ring may be secured over eachsensor 354 to temporarily secure sensor to flange member 352.

In another exemplary arrangement, sensor 354 may be powered throughcircuit board 306. More specifically, sensors 354 may be electricallyconnected to circuit board 306. Additional wires electrically connectcircuit board 306 to a power source to provide power not only to lightscarried by illuminating ring 350, but also to sensors 354.

Operation of surgical access assembly will be described in connectionwith a process flow 400 illustrated in FIG. 13 . However, as an initialnote, while use of surgical access assembly 100 is initially describedin connection with a tissue resection operation, it is understood thatsurgical access assembly 100 may simply be used to provide access to anarea of interest within the brain to permit a user to interrogate thearea of interest to learn about any abnormalities and/or diseases forevaluation and development of a treatment protocol, and/or to apply atherapy or treatment to deep seated locations within the brain.

Generally speaking, before any procedure is decided upon, a patient willfirst present with symptoms or deficits requiring evaluation. Thus, thestart of process flow 400 begins with a surgeon making a determination402 of the cause of such symptoms/deficits/abnormalities. In someinstances, causes for such symptoms/deficits/abnormalities may bevisibly apparent such that a determination may be made through use of avariety of imaging modalities, including, but not limited to, MRI or CTimaging. The process then proceeds to step 404.

If the determination from step 402 finds that a brain condition isfound, such as a tumor, hematoma, or other abnormality, an additionaldetermination is required. More specifically, a location of the braincondition is determined in step 404. If the imaging determines that anarea of interest is located in the intra-axial/subcortical space, theprocess flow continues to step 406. However, if a brain condition islocated in other, more easily accessible areas of the brain, the processflow stops.

As discussed above, any suitable imaging modality may be utilized todetermine if a brain condition exists, and if so, where that braincondition is located. FIGS. 14A and 14B illustrate examples of imagingresults from an MRI. More specifically, an area of interest 500, in thiscase a tumor, may be seen deep in the subcoritcal space.

Once area of interest 500 is located, at step 406 an additional imagingsequence is employed to determine the location of eloquent structuressuch as vessels and fiber tracts and the associated fascicles so as toplan the safest access route to the area of interest. Exemplaryarrangements for accomplishing this step include CT-Angiography and MRIwith Diffusion Tensor Imaging (DTI) sequences. DTI allows for thedetermination of directionality as well as the magnitude of waterdiffusion along the communication “wiring” pathways called fiber tractsand fascicles. This kind of MRI imaging can provide imaging to allow forthe estimation of potential damage to nerve fibers that connect theareas of the brain which can be affected by a stroke, for example, tobrain regions that are distant from it, and can also be used tovisualize white matter fibers in the brain and can map (trace image)subtle changes in the white matter associated with functional diseasessuch as multiple sclerosis and epilepsy, as well as assessing diseaseswhere the brain's wiring is abnormal, such as schizophrenia, as well astumor involvement.

Diffusion Tensor Tractography (DTT) may also be used. DTT allows fornoninvasive tracking of neuronal fiber projections in a living humanbrain. White matter fiber trajectories are reconstructed throughout thebrain by tracking the direction of fastest diffusion, which is assumedto correspond to the longitudinal axis of the tract. Diffusion tensortractography provides insight into white matter integrity, fiberconnectivity, surgical planning, and patients' prognosis. Once theimaging information has been analyzed, the process then proceeds to step408.

Referring to FIG. 15 , an example of DTI imaging of the brain shown inFIGS. 14A and 14B is depicted. A map of fascicles and other vessels areillustrated in FIG. 15 , including major vessels 502 that are shownspread around area of interest 500. Such images provide the surgeon withvaluable information about potential avenues for access tracts to areaof interest 500.

In step 408, a plan for the operative trajectory is developed. Morespecifically, imaging information is used to plan (either manually orwith software) the access tract/pathway to achieve fiber tractinvolvement during access to the area of interest. In evaluating fibertract involvement from a potential access tract/pathway, considerationof fiber tract importance may be based on an individual patient'soccupational and personal needs and/or preference. Once a pathway hasbeen planned, the process proceeds to step 410.

In step 410, image data from the MRI/DTI and CT/CTA image sequenceobtained during step 406 is input into an intraoperative navigationsystem. Intraoperative navigation systems may be used to provide directvisualization of area of interest 500 in real time, as surgical accesssystem 100 is being positioned within the brain. The method thenproceeds to step 412.

Once the procedure has been planned and the image data has been uploadedto a navigational system, step 412 requires that the appropriate sizedsurgical access assembly 100 is selected. First the appropriate size ofa craniotomy must be determined. Further, the present disclosurecontemplates that different diameter and length sizes of surgical accessassembly 100 may be employed, the size depending on the particularlocation of area of interest 500. Accordingly, step 412 requires thatthe surgeon select the appropriate length and diameter of surgicalaccess system 100 to be used, based on the physical and locationcharacteristics of the area of interest 500. Once surgical accessassembly 100 is selected, the process proceeds to step 414.

In step 414, the surgeon creates the craniotomy and Dural accessincision. The process then proceeds to step 416.

In step 416, the obturator 104 is inserted into outer sheath 102 untilgrip ring 120 abuts first stop member 176, as shown in, for example FIG.2 . Navigation member 112 is then operatively connected to obturator104.

As discussed above, various types of navigation members 112 may beemployed with surgical access assembly 100. In one exemplaryconfiguration, navigation member 112 is configured as a probe (as shownin FIG. 2 ). In this configuration, navigation member 112 is insertedthrough access opening 188 of grip member 178 until a distal tip 417 ofnavigation member 112 is deposited into depression 199 (see FIG. 9B).Depression 199 is formed so that distal tip 471 of navigation member 112is positioned within the same plane as distal tip 132 of outer sheath102, when obturator 102 and outer sheath 104 are assembled together asshown in FIG. 2 . Locking member 110 may be tightened to fixedly retainnavigation member 112 within obturator 102. A portion of navigationmember 112 will extend proximally from grip member 178 and will beoperatively connected to a navigation system that includes a screen thatvisually illustrates the information obtained from the imagingsequences, along with the trajectory of surgical access system 100.Thus, with the navigation member 112 operatively connected to anavigation system, the position of distal tip 132 of outer sheath may beindicated, in real time, while surgical access system 100 is beingnavigated within a body.

In another configuration, the software operating the navigation systemmay further be provided with an offset dimension that corresponds to adistance D3 between distal tip 174 of obturator 104 and distal tip 132of outer sheath. In this arrangement, a dotted line may appear on thenavigation screen that indicates where distal tip 174 of obturator 104is located, in real-time.

Navigation member 112 may further be provided with image guidanceposition indicators, such as an array of reflectors of the type use inconnection with optical image guidance systems. The infrared reflectorsused with such a system are mounted to a handle of a probe-likenavigation member 112 in a customary triangular configuration calibratedto identify the tool to the image guidance system. Such imaging systemsare available, for example Medtronic Surgical Navigation Technologies(Denver, Colo.), Stryker (Kalamazoo, Mich.), and Radionics (BurlingtonMass.).

Typically, the positioning of the indicators is calibrated such that theimage guidance system can project an image of the tool onto a display ofimages of the patient's brain, such as MRI images used to plan surgery.Thus, as discussed above, as surgical access system 100 is inserted, thesurgeon can see the relative position of system 100 relative to thestructures of the brain as reflected on images, and particularly withrespect to the target tissue.

Other guidance systems, such as magnetic or electromagnetic or radiotransmitting systems may also be used, and the illustration of infraredreflectors and discussion of optical image guidance systems areexemplary only and are not intended to be limiting. In addition, whilethe exemplary method has been described in connection with superimposingan image of surgical access system 100 onto a pre-operative image, it iscontemplated that real-time imaging capability may be utilized and thatthe image of surgical access system 100 may then be shown in relation tothe surrounding tissue structures on a real time image.

In another exemplary configuration, an RFID chip may be embedded inobturator 104 that operatively communicates information to a navigationsystem or other surgical system about the specific attributes, such as,but not limited to, length and diameter. This information may be used tofacilitate placement with the navigation system or other systems forinformation display or trajectory and location calculations duringplacement of obturator 104.

In yet another exemplary arrangement, as shown in FIGS. 16A-16B, analternative embodiment of an obturator 504 may be used, wherein theobturator 504 is configured with a post 512 that is configured tooperatively attach a navigation array. Post 512 may be detachably orpermanently connected to grip member 578 of obturator 104. For example,as shown in FIG. 16A, post 512 is configured to be selectivelydetachable and may be used to capture a small coil 513 for Mill trackingof surgical access assembly 100. A portion of post 512 may be threadedand an access opening 588 formed in a proximal face of grip member 578have be provided with corresponding threads (not shown) so as to affixpost 512 to obturator 504. Other manners of selectively affixing post512 to obturator 504 are also contemplated, including, but not limitedto, a locking member 110 arrangement similar that shown in FIG. 2 . Asalso discussed, post 512 need not be selectively detachable. Indeed, itis contemplated that post 512 may be permanently affixed to obturator504, in any suitable manner, whereby the navigation array may be securedto post 512. In yet another alternative arrangement, obturator 504 maybe configured such that a post, which is an element of the array itself,may be attached.

In still a further alternative arrangement, referring to FIGS. 16C-16D,a coil sensor 513′ may be configured to be disposed about an outerperiphery of post 512. In this arrangement, coil sensor 513′ is slid orotherwise mounted to post 512 such that when post 512 is operativelyattached to obturator 504 coil sensor 513′ is captured between a portionof grip member 578 and a proximal end portion 514. A connecting wire 516operatively attaches coil sensor 513′ to an image position console 518.

Once surgical access assembly 100 is assembled and operatively connectedto a navigational system, the process then proceeds to step 418, inwhich surgical access assembly 100 is navigated to area of interest 500.In one exemplary arrangement, distal tip 178 of obturator 104 isdirected to a furthermost outer margin of area of interest 500. In otherarrangements, distal tip 178 is positioned directly at the area ofinterest 500. Referring to the arrangement in FIG. 14B, for example,surgical access assembly 100 is directed along a trajectory T thatextends through area of interest 500 to a location 501 that may bepositioned within the margins of area of interest 500 or even slightlybeyond the margin. In other words, surgical access system may bedirected to be positioned at or adjacent an area of interest 500.

Due to the tapered configuration and closed, radiused distal tip 174 ofobturator 104, as well as the radiused distal tip 132 of outer sheath102, as surgical access assembly 100 is inserted into the brain andnavigated to area of interest 500, tissue is gently pushed to eitherside of surgical access assembly 100, so as to atraumatically dilatetissue, while minimizing trauma to the tissue. Further, because surgicalaccess assembly 100 is operatively connected to navigation member 112,as surgical access assembly 100 is being inserted into the brain tissue,navigation member 112 may cooperate with an imaging modality toproviding real-time information concerning fiber tact in trajectory T,thereby allowing the surgeon to minimize fiber tract compromise ordamage during insertion of surgical access assembly 100. Once surgicalaccess assembly 100 is positioned at area of interest 500, the processproceeds to step 420.

As step 420, navigation member 112 removed from or detached fromsurgical access assembly 100. The process then proceeds to step 422.

Once navigation member 112 is removed, outer sheath 102 is thenoperatively positioned with respect to area of interest 500. Morespecifically, as shown in FIG. 17A, outer sheath 102 is decanted withrespect to obturator 104 such that distal end 108 of outer sheath 102 ismoved toward distal end 106 of obturator 104, as indicated by arrow M.This action is accomplished by grasping grip ring 120 with one handwhile maintaining obturator 104 stationary, such, for example, graspinggrip member 178 with another hand. Grip ring 120 may be gently rotatedand/or swiveled with respect to a central axis of obturator 104 toenable outer sheath 102 to be moved distally with respect to obturator104. First stop member 176 aids in gripping and manipulating outersheath 102, in that a gap 423 (see FIG. 2 ) is created between endsurface 158 and a distal end surface of grip member 178. Outer sheath102 is decanted until grip ring 120 aligns with indicator 194A (see FIG.7A). Indicator 194A is spaced from first stop member 176 a distance thatgenerally corresponds to the length of distal tip portion 172 ofobturator 104. Accordingly, when grip ring 120 is aligned with indicator194A, distal end 108 of outer sheath 102 is aligned tip member 174 ofobturator 104. Moreover, outer sheath 102 is positioned within area ofinterest 500. The process then proceeds to step 424.

In step 424, once outer sheath 102 is appropriately positioned,obturator 104 is then removed from outer sheath 102, as shown in FIG.17B. More specifically, outer sheath 102 is maintained to be relativelystationary at area of interest 500, and obturator 104 is moved in aproximal direction until fully removed from outer sheath 102. Thisaction results in outer sheath 102 forming a pathway to area of interest500; a pathway that not only circumvents the need to cross the bloodbrain barrier for the delivery of therapy, but also provides directaccess to the area of interest within the patient, thereby allowingpreviously inaccessible brain tissue to be accessed and interrogated, aswell as permitting therapy to be applied, as will be explained infurther detail below.

In other embodiments, rather than provide obturator 104 with navigationmember 112, or in addition to providing obturator 104 with navigationmember 112, as discussed above, outer sheath 102 may be provided withand RFID chip or sensor. With this configuration, the RFID chip orsensor of outer sheath 102 cooperates with the navigation system therebymaking outer sheath 102 visible to the user on the navigation system,independent of obturator 104. Thus, once obturator 104 is removed fromouter sheath 102, the location within the patient of outer sheath 102will still be visible to the navigation system.

More specifically, the navigation system works with the additionalimages taken during the imaging sequence in step 406. The images takenin step 406 are uploaded into the intraoperative navigation system, asindicated in step 410. The RFID chip and/or sensors are configured to beread by the navigation system and place an image of outer cannula 102,thereby allowing the surgeon to direct visualize the location of outercannula 102, while positioned within the patient.

Once outer cannula 102 is positioned at the area of interest 500 andobturator 104 is removed, one of the illuminating rings 300, 350 may beattached to outer sheath 102.

In one exemplary arrangement, rather than employing an RFID chip and/orsensor in outer sheath 102, illuminating ring 350 may be provided withsensors or reflective balls, as described above in connection with FIGS.11H-I. With this type of configuration, once obturator 104 and outersheath 102 have been delivered to area of interest 500 and obturator 104is removed from outer sheath 102, illuminating ring 350 is operativelyconnected to outer sheath 102. Because illuminating ring 350 includes anavigational element, such as sensors and/or reflective balls, onceilluminating ring 350 is connected to outer sheath 102, the navigationsystem will be able to “read” where outer sheath 102 is located in thebody. In other words, an image of outer sheath 102 will be able to beprojected onto the static images uploaded into the navigational system.

Once outer sheath 102 is placed in its desired location, the processthen proceeds to step 426.

In step 426, outer sheath 102 is then secured in place so as to preventcranial pressure or general manipulation of instruments passing in andout of the sheath 102 from pushing or dislocating outer sheath 102 outof the brain tissue. In one exemplary arrangement, a securing member maybe utilized with small openings 150 on grip ring 120 to temporarilysecure outer sheath 102. For instances where illuminating ring 300 isused with surgical access assembly 100, small openings 309 inilluminating ring 300 align with small openings 150 of grip ring.Accordingly, securing members may also be utilized with small openings309. However, the securing member may be secured so as to permit alimited degree of movement, as will be discussed below, so as to resultin a floating system that permits selective repositioning. Suitablesecuring members include, but are not limited to, bridle sutures,flexible bands with retaining hooks, or even repositionable retractorarms. Additional alternative securing arrangements are disclosed below.Once outer sheath 102 is secured, the process then proceeds to step 428.

In some procedures where it is desired to remove tissue from the brain,the process proceeds to step 428, whereby debulking area of interest 500may be conducted. Traditionally, a patient is given medication, such as,for example, Mannitol, before an intracranial operation to reduceintracranial pressure (ICP) of the brain prior to the surgery. Indeed,ICP is often experienced by patients due to the natural response of thecraniotiomy and/or the present of an abnormality within the brain. Thepresent inventors have found that it may be advantageous to omit orminimize the use of medication for reducing ICP. More specifically, bynot reducing ICP, because the brain tends to occupy the available spacewithin the skull, after obturator 104 is removed from outer sheath 102,the target tissue may have a tendency to flow into, and present itselfinto the open distal end 108 of outer sheath 102, due to the cranialpressure. Area of interest 500 may actually move into outer sheath 102on its own, thereby assisting in the delivery and minimizingmanipulation required of outer sheath 102 during the process.

It is contemplated that a wide range of surgical devices may be insertedinto outer sheath 102 to remove tissue abnormalities. In one exemplaryarrangement, it is contemplated that outer sheath 102 may have an innerdiameter up to approximately 20 mm, to allow multiple instruments, suchas graspers, dissectors, scissors, cautery and suction instruments to beinserted through outer sheath 102 to perform surgery.

One exemplary surgical device that may be used is the NICO MYRIAD®manufactured and distributed by Nico Corporation of Indianapolis,Indiana Referring to FIG. 18 , an exemplary surgical cutting device 640is shown, such as that disclosed in co-pending, and co-owned with theassignee of the present application, U.S. patent application Ser. No.12/389,447, the contents of which are incorporated by reference in itsentirety. Surgical cutting device 640 includes a handpiece 642 and acutting element that includes an outer cannula 644 and an inner cannula(not shown). In one exemplary configuration, handpiece 642 is configuredwith a generally cylindrical shape. Handpiece 642 may be sized andshaped to be grasped with a single hand. Handpiece 642 also includes alower housing 650 comprising a proximal section 646 and a distal section648. A front housing section 655 may be connected to a cam housingpositioned in distal section 648. An upper housing 652 is also provided.The cutting element is mounted to upper housing 652 and may be fluidlyconnected to a tissue collector 658. In one exemplary arrangement,tissue collector 658 may be operatively connected directly to upperhousing 652. Alternatively, tissue collector 658 may be remotelyconnected to the cutting element by appropriate tubing. A vacuum line(not shown) may be connected to a proximal end of tissue collector 658to direct tissue into the cutting element, as well as to deliver severedtissue to tissue collector 658. A rotation dial 660 for selectivelyrotating the outer cannula 644 with respect to handpiece 642 is alsomounted to upper housing 652, to provide controlled cutting action.

Use of surgical device 640 is advantageous in that space is limited toeffectuate tissue debulking, such that use of traditional surgicalscissors may be challenging, especially when other instruments areinserted into outer sheath 102 simultaneously. Moreover, fibrosity of atumor may present challenges for the use traditional suction debulkingdevices. Traditional graspers operate by tearing tissue of interest.However, the tearing action may become problematic if vessels orfascicles are too close to the tissue being torn in that such vessels orfascicles may also be torn.

In step 428, as area of interest 500 is cytoreductively debulked, it maybecome necessary to reposition or move outer sheath 102. Ifrepositioning is necessary, the process moves to step 432. To that end,in one exemplary arrangement, manipulation members may be provided.Examples of manipulation members 700 and 700′ are illustrated in FIGS.19A-19B. Manipulation member 700 comprises a handle member 702 thatsupports an armature 704, and a hook element 706 that extends fromarmature 704. Hook element 706 is sized to fit within small openings 150and 309 disposed within grip ring 120 and illuminating ring 300,respectively. In operation, hook element 706 is engaged with a smallopening 150/309 and handle member 702 is used to gently push or pullouter sheath 102. Because outer sheath 102 is only loosely secured,outer sheath 102 may be selectively moved slightly for improvedvisualization or to access tissue. After outer sheath 102 has beenrepositioned, or if repositioning of outer sheath 102 is not necessary,the process moves to step 434, and cytoreduction of area of interest 500continues.

In an alternative arrangement, manipulation member 700′ may be securedto a flexible holder member 710. Manipulation member 700′ comprises anarmature 712 that carries a hook element 714 and an engagement portion716. Engagement portion 716 operatively engages holder member 710 so asto fixedly secure manipulation member 700′ to holder member 710, therebyfreeing a surgeon's hand, once outer sheath 102 is positioned. It isunderstood that multiple manipulation members 700/700′ may be utilizedto permit a surgeon to selectively push or pull outer sheath 102.

Referring to FIGS. 19C-19F, other alternative arrangements for holdingouter sheath 102 during a procedure are shown. More specifically, FIGS.19C-19D illustrate a holding arrangement 720 that may be used with aGreenberg retractor assembly. Holding arrangement 720 comprises bodyportion 722, an engagement barrel 724, and a retaining member 726.

Body portion 722 may be configured as a relatively thin shaft. In oneexemplary arrangement, body portion 722 includes at least two bendpoints 728 a and 728 b that are separated by a section of shaft 730.Bend point 728 a is positioned proximal of a distal end of body portion722, defining a retaining section 732. Bend point 728 b is positionedproximal of shaft section 730. Bend point 728 b and a proximal end 734cooperate to define a proximal shaft section 736. Bend points 728 a and728 b serve to axially space retaining section 732 from proximal section734. In one arrangement, as shown in FIG. 19D, shaft section 730 isdisposed at an approximately 45° angle. In another exemplary arrangement(not shown), shaft section 730 may be oriented at an approximately 90°angle. It is also contemplated that shaft section 730 may be deposed atother angles. In some exemplary arrangements, bend points 728 a, 728 bmay be eliminated such that retaining section 732 and proximal section736 are arranged along a common axis. Retaining section 732, shaftsection 730 and proximal section 736 may be integrally formed together,or constructed as separate elements that are connected together.

Retaining section 732 terminates at its distal end 738 in retainingmember 726. As best seen in FIG. 19C, retaining member 726 is configuredas a shepherd's hook that is configured to curve back toward retainingsection 732, but defining a gap 740 between an end 742 of retainingmember 726 and retaining section 732. Retaining member 726 may beintegrally formed with retaining section 732, or formed as a separatecomponent that connects with retaining section 732. Retaining member 726is configured similar to a spring clip such that retaining member 726snaps partially around outer sheath 102.

Mounted on proximal section 736 is engagement barrel 724. Engagementbarrel 724 is configured for selectively rotation about proximal section736. In one exemplary arrangement, on either end of engagement barrel724, stop members 744 are disposed. In operation, engagement barrel 724is positioned within Greenberg adapter and clamped thereto. Stop members744 serve to prevent engagement barrel 724 from being unintentionallyextracted from the Greenberg adapter. However, due to the configurationof engagement barrel 724 and placement of stop members 744, engagementbarrel 724 is permitted to move a predetermined amount in a linearfashion. Moreover, because engagement barrel 724 is configured toselectively rotate about proximal section 736, outer sheath 102 may beselectively pivoted along the Y direction to a desired position.Further, because retaining member 726 is configured as a shepherd's hookwith the gap 740, outer sheath 102 may be pivoted in the X direction.Thus holding arrangement 720 allows for selective positioning of outersheath 102.

An alternative holding arrangement 750 is shown in FIGS. 19E-19F.Holding arrangement 750 is configured to be used with a Sugita adapter(not shown). Holding arrangement 750 is similar to holding arrangement720 comprises body portion 752, an engagement barrel 754, and aretaining member 756.

Body portion 752 may be configured as a relatively thin shaft and mayinclude one or more bend points 758 a-758 b. Like holding arrangement720, bend points 758 a, 758 b serve to axially offset a retainingsection 762 from a proximal section 764. A shaft section 760 ispositioned between bend points 758 a, 758 b.

Retaining section 762 terminates at its distal end 768 in retainingmember 756. As best seen in FIG. 19E, retaining member 756 is configuredas a shepherd's hook that is configured to curve back toward retainingsection 762, but defining a gap 770 between an end 772 of retainingmember 756 and retaining section 762. Retaining member 756 may beintegrally formed with retaining section 762, or formed as a separatecomponent that connects with retaining section 762. Retaining member 756is configured similar to a spring clip such that retaining member 756snaps partially around outer sheath 102.

Mounted on proximal section 764 is engagement barrel 754. Engagementbarrel 754 is configured for selectively rotation about proximal section764. A mounting member 774 is fixedly secured to engagement barrel 754.Mounting member 774 is configured to be received within a Sugita clampmechanism. In one exemplary arrangement, on a distal end of engagementbarrel 754, a stop member 776 is disposed. In operation, engagementbarrel 754 is positioned within the Sugita adapter and clamped thereto.Stop member 776 serves to prevent engagement barrel 754 from beingunintentionally extracted from the Sugita adapter. However, due to theconfiguration of engagement barrel 754 and placement of the stop member776, engagement barrel 754 is permitted to move a predetermined amountin a linear fashion. Moreover, because engagement barrel 754 isconfigured to selectively rotate about proximal section 764, outersheath 102 may be selectively pivoted along the Y direction to a desiredposition. Further, because retaining member 756 is configured as ashepherd's hook with the gap 770, outer sheath 102 may be pivoted in theX direction. Thus holding arrangement 750 allows for selectivepositioning of outer sheath 102.

Yet another alternative arrangement of a holding arrangement 780 isshown in FIGS. 19G-19J. Holding arrangement 780 is configured tomaintain longitudinal alignment of an exoscope 782 and outer sheath 102.In this arrangement, light is provided to outer sheath 102 (and hence tothe surgical site/area of interest) via exoscope (Karl Storz Endoscopy,Germany) 782. Thus, while exoscope 782 is spaced apart from outer sheath102, an effective visual line of sight and maintenance of projection oflight to the bottom of outer sheath 102 may be achieved.

Holding arrangement 780 is provided with an alignment tool 784.Alignment tool 784 is configured with an outwardly extending arc portion786. More specifically, outwardly extending arc portion 786 arcs awayfrom a longitudinal axis LA that passes through a longitudinal spacebetween exoscope 782 and outer sheath 102, when exoscope 782 and outersheath 102 are aligned. In this manner, arc portion 786 cooperates withexoscope 782 and outer sheath 102 to define a working space betweenexoscope 782 and outer sheath 102. This arrangement permits a user to beable to pass instruments in and out of outer sheath 102, as well as thearea of interest.

In one exemplary arrangement, arc portion 786 is defined by a pair ofwire-like members 786 a, 786 b (best seen in FIG. 19H). Members 786 a,786 b are configured to be substantially rigid so as to maintain theposition of outer sheath 102 with respect to exoscope 782.

In addition to arc portion 786, alignment tool 784 further includes aexoscope attachment harness 788 and an outer sheath attachmentarrangement 790. Exoscope attachment harness 788, best seen in FIG. 19H,is comprised of a retaining mechanism 792 attached to a reinforcementsection 794. Reinforcement section 794 extends upwardly in the samedirection as longitudinal axis LA from members 786 a, 786 b. Retainingmechanism 792 is configured to at least partially extend around an outerperiphery of exoscope 782 in a snap-fit or clamping arrangement. In oneexemplary arrangement, retaining mechanism 792 is integrally formed withreinforcement section 794. Similarly reinforcement section 794 may alsobe integrally formed with arc portion 786. A bend point 795 joins archportion 786 with reinforcement section 794.

As best seen in FIG. 19I, outer sheath attachment arrangement 790includes connector members 796 a, 796 b that are configured to bereceived within openings formed in grip ring 120, sufficiently spacedapart such that alignment tool 784 may maintain a desired position. Inone exemplary arrangement, connector members are pins that are joined tomembers 786 a, 786 b by bend points 797 a, 797 b. With this arrangement,outer sheath 102 may be selectively pivoted about longitudinal axis LA,thereby allowing some degree of flexibility in positioning outer sheath102 at the area of interest.

Referring to FIG. 19J, an alternative arrangement for connecting arcportion 786 to outer sheath 102 is shown. In this arrangement, an end ofone of the members 786 a is configured as a Shepard's hook 798, similarto that shown in the arrangements of FIGS. 19C and 19E. As explainedabove, this arrangement allows the outer sheath 102 to be pivoted in theX direction, thereby permitting selective positioning of outer sheath102.

Outer sheath 102 is configured such that multiple instruments may beinserted simultaneously therewithin, thereby increasing the speed andsafety of surgical procedures. In one exemplary arrangement, anendoscope may be partially inserted and held to one side of outer sheath102, to provide an image of area of interest 500 to a monitor, while asurgical instrument, such as surgical instrument 640 is also insertedwithin outer sheath 102. Illuminating ring 300 may also be used, withthe endoscope and the surgical instrument being inserted through accessopening 308 that aligns with opening 146 of grip ring 120. Becauseilluminating ring 300 provides the necessary light for outer sheath 102,a relatively small diameter endoscope may be use, thereby increasing theavailable space within outer sheath 102 for other surgical instruments.In another exemplary configuration, the surgeon may have both a surgicalinstrument and a cautery instrument simultaneously inserted into outersheath 102, thereby permitting the surgeon to cauterized vessels thatare encountered during the procedure.

In another exemplary arrangement, during the procedure, fluorescing dyemay be introduced into the patient, either before surgery or during thesurgery. One such dye is Gliolan (5-Aminolevulinic Acid), however othersuitable dyes may also be used. The fluorescing dye may be introduced byany suitable methods, including, but not limited to, injecting thepatient with the dye, providing the dye orally to the patient prior tosurgery, or even injecting the dye in situ through outer sheath 102. Inone exemplary arrangement, the dye is configured to bond to proteins ofabnormal cells such that the cells are visually distinguishable fromhealthy cells. With this visual indication of healthy vs. abnormaltissue, the surgical instrument may be more efficiently used toidentify, as well as resect abnormal tissue. In other embodiments, lightdelivered through outer sheath 102 has a predetermined wavelength thatis configured to interact with the dye to illuminate or fluorescecertain tissues. For example, illumination cap 300 may be provided withLED lights of a preselected wavelength that operatively interacts with apreselected dye to illuminate abnormal tissue and assist withdifferentiating healthy tissue from diseased tissue.

In another exemplary configuration, a light probe or fiber optic bundle(not shown) may be inserted into outer sheath 102 to assist withdifferentiation between healthy tissue and abnormal tissue. In onearrangement, the probe/bundle is simply inserted into outer sheath 102.The probe/bundle is operatively connected to a console such that thereflected light is delivered to the console. A sensor in the console(i.e., the sensor is remotely located from the point of detection,receives the reflected light to trigger a signal to the user based onpredetermined parameters. In other words, the natural florescence of thetissue is then reflected back to the console to inform the user whetheror not the tissue is diseased or abnormal. For those operations wheredebulking or tissue sampling is being conducted, the surgical device canbe inserted into outer sheath 102 simultaneously with the probe/bundle,thereby improving the accuracy and efficiency of the debulkingprocedure.

In another exemplary configuration, the surgical device may be furtherprovided with a delivery sleeve 800 that mounts to surgical device 640,and example of which may be found in FIG. 20 . Various embodiments ofdelivery sleeve 800 may be found in co-pending, and co-owned with theassignee of the present application, U.S. patent application Ser. No.13/269,339, the contents of which are incorporated by reference in itsentirety. As may be seen in FIG. 20 , delivery sleeve 800 generallyincludes at least two lumens, a first lumen 802 which is configured toreceive outer cannula 644 of surgical device 640, and a second lumen 804which is configured to receive an optical device, such as a light probeor a fiber optic bundle (not shown). Use of this arrangement permits useof additional surgical tools/instruments within outer sheath 102. Morespecifically, as the optical device is supported within the deliverysleeve 800, which, in turn, is connected to the surgical device, thesurgeon can simultaneously differentiate between abnormal and healthytissue, and resect tissue, all with by just holding the surgical device640. As a result, the surgeon may also choose to utilize a separatecautery device within outer sheath 102 to permit cauterization of anyvessels during the resection, in real time, and without requiringremoval of the surgical device 640.

Because outer sheath 102 may be directly positioned at area of interest500 in such a manner as to avoid unnecessary damage to criticalstructures, and because surgical device 640 may be placed directly atthe sight of area of interest, utilizing surgical access system 100provides the ability to resect most of an area of interest 500, such atumor. As one of ordinary skill in the art can appreciate, the more thata tumor is resected and removed, the less therapy is required fortreatment. In other words, the more diseased tissue there is resected,the less diseased tissue there is to destroy.

In cases where cytoreduction is the objective to be performed, onceresection of area of interest 500 has been completed, the process thenproceeds to step 436. In step 436 a decision is made to either removeouter sheath 102 or to leave outer sheath 102 in position. Morespecifically, for some therapy applications, removal of outer sheath 102may be more effective than leaving outer sheath in place to deliver thetherapy. If the decision is made to remove outer sheath 102, afterremoval of outer sheath 102, the process 400 proceeds to step 438.

As one of ordinary skill in the art may appreciate, the naturalelasticity of brain tissue will maintain access or a corridor to area ofinterest 500 for period of time, even after removal of outer sheath 102.In step 438, while the corridor is still intact after removal of outersheath 102, in one exemplary arrangement, a delivery device may beinserted into the corridor to deliver irrigation to the surgical site.In some instances, a syringe may be inserted into the corridor todeliver an irrigating fluid, such as saline directly to the surgicalsite. In another exemplary configuration, a drainage catheter (which isconfigured with a plurality of small openings at its distal end) isdelivered into the corridor such that the distal end of the catheter isplaced at or adjacent the surgical site. Irrigating fluid is thenintroduced into the proximal end (such, as for example, by operativelyattaching a syringe barrel to the proximal end), to deliver theirrigating fluid to the surgical site. The irrigating fluid flushes outdebris and assists in the brain tissue's natural tendency to close backin on itself. Once the surgical site has been irrigated, it may also bedesirable to deliver certain therapies directly to the surgical site,thereby avoiding therapy delivery and uptake issues traditionallyencountered by systemic approaches. For example, certain therapies thatmay be provided in liquid form may be directly injected through thecorridor, just prior to the tissue closing back in on itself. Becausethe corridor is closing, the therapy will be held in place at thesurgical site, thereby increasing its effectiveness at the site andsurrounding tissue.

In some therapy methodologies, outer sheath 102 may be necessary to aidin the delivery and/or placement of such therapy, as will be explainedin further detail below. Accordingly, if the decision in step 436 ismade to keep outer sheath 102 in place after completion ofcytoreduction, the process 400 proceeds to step 442.

In step 442, area of interest/surgical site 500 is irrigated to againremove any debris from the area. Irrigation may be performed in the samemanner as discussed in step 438, except through outer sheath 102. Onceirrigation is complete, the process proceeds to step 444.

In step 444 a therapy is delivered to area of interest 500. In oneexemplary configuration, intraoperative radiotherapy (IORT) may beemployed, so as to deliver therapy directly to area of interest 500through outer sheath 102. In one exemplary configuration, an implantabletherapy may be applied to area of interest 500. Example of animplantable therapy include: bioabsorbable radiation pellets, wafers ormesh, such as, for example, those manufactured by Nano-Rad LLC. Otherexamples include, but are not limited to, titanium capsules or seedswith radiation contents, bioabsorbable gels or foams that containradioactive, chemotherapy or immunotherapy agents.

In another exemplary configuration, a balloon catheter may be used toperform brachytherapy following the removal of diseased tissue at areaof interest 500. For example, a balloon catheter may be inserted throughouter sheath 102 and delivered to area of interest, and then the ballooncatheter may be inserted with a predetermined amount of radioactivesolution followed by the delivery of radiation to the surroundingtissues. A commercially available catheter that may be used includes theGliaSite balloon catheter, with an Iotrex radioactive solution. Use of aballoon catheter may provide a more targeted delivery of liquidradiation, thereby reducing impact on brain tissues surrounding thediseased tissue.

In another exemplary arrangement, an electron beam driven X-ray sourcemay be provided. One such exemplary configuration is the ZeissINTRABEAM®. The electrons are generated and accelerated in a main unitand travel via an electron beam drift tube which is surrounded by aconical applicator sheath such that its tip lies at an epicenter of anapplicator sphere to provide a point source of low energy X-rays at thetip. With this configuration, a nearly isotropic field of low energy isemitted.

In operation, the applicator sheath is inserted through outer sheath 102and into the surgical cavity at area of interest 500. An intraoperativeultrasound may be performed to determine the distance of the applicatorsurface to the skin, to avoid significant skin doses. The applicatorsheath may be secured into place by the surgeon using subcutaneoussutures around the neck of the sphere, similar to that described abovein connection with outer sheath 102.

In another exemplary arrangement, a photodynamic therapy may be used,whereby a predetermined chemical composition may provided to the patientand the chemical composition may be selectively activated by apredetermine wavelength, thereby achieving a therapeutic reaction. Forexample, in one exemplary configuration, illuminating ring 300 may beturned on to achieve the therapeutic reaction. In another exemplaryconfiguration, a light source, such as, for example, a fiber opticbundle, may be directed through outer sheath 102, either directlythrough outer sheath 102 or through delivery sleeve 800.

In yet another exemplary configuration, external beam high frequencyultrasound or interstitial high frequency ultrasound may also bedelivered through outer sheath and directly to area of interest 500.

In yet a further exemplary configuration, as shown in FIGS. 21A-21B, animplantable delivery device 900/900′ may be provided. Implantabledelivery device 900/900′ includes a neck portion 902 that is connectedto a body portion 904/904′. Both neck portion 902 and body portion904/904′ may be constructed of a relatively soft and flexible material.Body portion 904/904′ defines a reservoir for holding a therapeuticagent therein. A proximal end 905 of neck portion 902 is largely closed,with access to an interior of implantable delivery device 900/900′ beingproviding by a luer port 906. More specifically, therapy agents areintroduced into delivery device 900/900′ through luer port 906. Asealing flange 908 may further be provided, that operatively connects toneck portion 902 to assist in holding implantable delivery device900/900′ in place within the brain.

In the arrangement shown in FIG. 21A, body portion 904 may be providedwith at least one small opening 910. In one exemplary arrangement, aplurality of small openings 910 are provided, and such openings may bespaced equi-distance from one another about the periphery of bodyportion 904. Small openings 910 are configured to permit the therapyagent that is introduced through luer port 906 to weep out of thereservoir formed by body portion 904 at a controlled rate to increaseeffectiveness. Alternatively, body portion 900 may be configured as apermeable membrane that permits slow and controlled passage of therapyfrom the reservoir to the brain tissue 1000.

In an alternative arrangement shown in FIG. 21B, body portion 904′ maybe provided with flexible finger-like projections 912. In one exemplaryconfiguration, projections 912 are spaced equi-distance from one anotherabout the periphery of body portion 904′. Projections 912 extendoutwardly from an outer periphery of body portion 904′ and may be formedwith channels that provide communication between the reservoir and smallopenings 914 configured at distal tips 916 of projections 912. Openings914 are configured to permit the therapy agent that is introducedthrough luer port 906 to weep out of the reservoir. Projections 914assist in frictionally retaining delivery device 900′ at a target site.

Referring back to process 400, if delivery device 900/900′ is employed,delivery device 900/900′ is inserted at area of interest 500 throughouter sheath 102. Once positioned, outer sheath 102 is removed, andsealing flange 908 is operatively connected to neck portion 902 suchthat luer port 906 is accessible. Sealing flange 908 is configured toextend over the periphery of the surgical access opening that was formedthrough the skull 1002, thereby providing protection for the exposedbrain tissue 1000. The therapeutic agent may be supplied to thereservoir formed by body portion 904/904′ either before delivery device900/900′ is positioned at area of interest 500, or after sealing flange908 is in place. Sealing flange 908, as well as body portion 904/904′and neck portion 902 may be configured with flexible material to allowfor sealing against the dura and bone of the brain.

In yet another alternative arrangement involving delivery device900/900′, a transfer material may be delivered through outer sheath 102,similar to a foam that is configured to conform to the cytoreducted areaof interest 500. The foam will allow continuous contact with the therapyagent that weeps through body portion 904/904′ to provide a controlleddosage of therapy to area of interest 500.

After surgery and therapy on the target tissue is complete, the processproceeds to step 446. In this step, the instruments used for surgeryand/or therapy are removed from outer sheath 102. As the target tissueis removed, brain tissue will naturally fill the void formed by removingarea of interest 500 so that healthy brain tissue underlying the nowremoved target tissue is adjacent the end of outer sheath 102. Outersheath 102 is then gently removed and the brain tissue will naturallyfill and reclaim the space formerly occupied by the abnormality andouter cannula 102, aided by the irrigation of area of interest 500.Moreover, as the brain tissue reclaims the space formerly occupied bythe abnormality and outer cannula 102, implanted therapies, such as, forexample, bioabsorbable radiation pellets, wafers or mesh, will be heldin place at area of interest 500 to provide effective treatment, alldelivered and unencumbered by the limitations normally encounteredattempting to cross the blood brain barrier. While this process may takeseveral minutes, it is relatively atraumatic. Once outer sheath 102 hasbeen removed, the process continues to step 448, whereby the dura, skulland scalp are then closed in a known manner and the process ends. In theexemplary cases whereby a treatment device may be implanted, fullreclaiming of the space is delayed due to the implant until implant isexplanted or absorbed.

Because the location of the area of interest will vary from patient topatient, in one exemplary arrangement, it is contemplated that surgicalaccess system 100 will be provided as part of a kit. More specifically,it is contemplated that a set of multiple obturators 104 may be providedthat have different lengths and/or diameters. The set may be provided ina container that is configured be sterilized, with obturators 104secured therein. It is also contemplated that a set of manipulationtools 700/700′ may also be provided with the kit, and that manipulationtools 700/700′ may be positioned within the container for selectivesterilization. Outer sheath 102 may be provided with the kit, in variouslengths and diameters that correspond to the lengths and diameters ofobturators 104 provided in the kit. However, in one exemplaryarrangement, outer sheaths 104 are provided separately as single usedevices, in sterilized pouches.

While the above-described system provides the advantage of creatingdirect access to an area of interest, including an area of interest inthe subcortical space, thereby permitting debulking of the area ofinterest to reduce the biological load of the abnormal tissue, as wellas delivery of therapy in-situ (without the encumbrance and limitationsencountered with systemic therapy delivery), for certain diseases,additional subsequent therapy may be warranted for increased therapeuticbenefits.

More specifically, to be able to define an effective subsequenttreatment therapy cocktail that will be effective on newly evolvedstrain of cells and tissue or disease that “morphs”, the abnormal tissueat the area of interest requires imaging to define the area of interest,needs to be accessed, requires interrogation (sampling with or without acytoreductive debulking of the area) to determine an appropriatetherapeutic cocktail for the newly evolved cells and tissue. Thisprocess may be required to be repeated at a specific time or at avariety of time intervals for the live of the patient to assure theappropriate management or cure of the disease.

In the case of functional diseases of the brain such as a Alzheimer's,Parkinson's, epilepsy, bi-polar, depression, etc., the cells andaffected tissues may not change or morph after the initial treatment butit may be useful to subsequently, image, access, interrogate the tissue(sample or debulk) the same or another area of interest after theinitial delivery of a therapy to determine the effectiveness of theprevious application to determine the response of the tissues to thetreatment regimen to determine the need for subsequent treatmentregimens and the nature of the therapeutic treatment required for thesubsequent therapy.

Referring to FIG. 22 , a process flow 1200 illustrating an additionalmethod of treatment is disclosed to address a second stage treatmentregime. Process flow 1200 begins a predetermined time period 1202 afteran initial resection and treatment process flow 400 (as shown in FIG. 13) has been completed. The need, if any, for process flow 1200 and thepredetermined time period 1202 will depend on the effectiveness of theinitial treatment and the nature of the disease being treated diseasestate-morphing, as well as the form of therapy that is originallyapplied. The process then proceeds to step 1204.

In step 1204, the area of interest 500 is re-imaged to determine theeffects of therapy on area of interest 500. In other words, step 402 ofprocess 400 is repeated. Such imaging includes, but is not limited to,MRI or CT imaging. The process then proceeds to step 1206.

In step 1206, a determination is made as to whether any disease isvisible after employing the imaging step 1204. For certain diseases, ifno visible disease is detected 1208, the process 1200 stops. For certainlow-grade gliomas, for example, no more intervention may be required.For other diseases, i.e., fast growing tumors such as gliomas, ifexternal imaging modalities fails to detect any visible disease, basedon the patient history including prior disease pathology, it may bewarranted to employ an in-situ imaging technique in step 1210. Someexamples of such techniques include, but are not limited tospectroscopy, MRI, ultrasound, florescence. If, after completion of step1210, no visible sign of disease are evident, the process stops.However, if after steps 1206 and 1210, the imaging step reveals visualevidence of disease, the process proceeds to step 1212.

In step 1212, many of the steps of the process flow 400 set forth inFIG. 13 is repeated. More specifically, steps 406-426 of process flow400 are repeated to create access to area of interest 500. Next theprocess proceeds to step 1214.

In step 1214, area of interest 500 is interrogated (such as, forexample, via additional cyto-reduction or just sampled/biopsy), similarto steps 428-434 in FIG. 13 . Indeed, after the initial treatmentprocess, the disease may have mutated such that the disease may be of aslightly different variant of the diseased tissue that was originallytreated. As such, use of the same therapeutic cocktail in in-situ may nolonger be effective. Accordingly, step 1214 involves interrogating thearea of interest 500 to gather and determine the necessary informationregarding the tissue makeup of the area of interest 500. Next, theprocess proceeds to step 1216.

In step 1216, tissue from area of interest 500 is analyzed to determinethe appropriate and effective therapy to treat area of interest 500. Inother words, evaluation of differentiating cells from area of interest500 may be utilized to provide the most effective treatment for thedisease. In some instances, immunotherapy may be utilized, wherebytissue samples taken from area of interest 500 are used to determine andsubsequently formulate a therapy of personalized medicine to thespecific disease mutation identified and analyzed in step 1216. Oneexemplary, non-limiting type of such immunotherapy is taught anddisclosed in co-pending U.S. application Ser. No. 13/352,069, thecontents of which are hereby incorporated by reference in its entirety.Once an appropriate therapy is determined, the process proceeds to step1218, whereby the therapy is applied to area of interest.

The therapy may be applied in any suitable manner. For example, in someinstances, it may be necessary to remove the outer sheath to deliver thetherapy, such as that taught in steps 438-440 in FIG. 13 . In othersituations, the outer sheath may remain in place and the chosen therapymay be delivered in a manner similar to steps 442-446 in FIG. 13 .

Once therapy has been appropriately delivered, the process then proceedsto step 1220 whereby the surgical access is closed in a manner similarto that which has been previously described above in connection withstep 448 in FIG. 13 . However, it is understood that the process flow1200 may be repeated as needed until the patient is deemed disease freeor the disease is managed to a point whereby it is not life threatening.

As described above, while the process using surgical access assembly 100has been described in connection with performing a surgical resectionprocedure and subsequent treatment methods, surgical access assembly 100may also be utilized for locating, evaluating and treating a variety ofCNS based disorders, such as functional diseases/abnormalities,metabolic/regulatory systemic conditions, addictions and painmanagement, without necessarily requiring surgical resection/debulking.More specifically, in such instances, surgical access assembly 100 isinserted into the brain at an area of interest, as discussed above,thereby providing a pathway to the area of interest. Once surgicalaccess assembly 100 is delivered to the area of interest and obturator104 is removed from outer sheath 102, the area of interest may beinterrogated to assist in determining an appropriate treatment and/ortherapy, or even the effectiveness of treatment or therapy previouslyutilized on the patient.

The interrogation of the area of interest may be conducted in anysuitable manner. Examples of interrogation include, but are not limitedto, tissue sampling and/or cytoreduction. In other embodiments,interrogation may include image based tissue interpretationtechnologies, such as, but not limited to MRI, CT, PET, ultrasound,fluorescence, spectroscopy, as well as all derivative sequences from aprimary imaging modality.

In other words, interrogation of the area of interest permits evaluationof biological/cellular activity from area of interest 500 to evaluate apreviously applied therapy, as well as provide the most effectivetreatment for the disease and/or abnormality. The evaluation resultingfrom the interrogation step permits a personalized treatmentplan/therapy to be delivered to effectively manage or treat a patient'sdisease or disorder. After the interrogation step, as discussed above,to the extent additional therapy is needed, such therapy can bedelivered through outer sheath 102 as discussed above or as isappropriate based upon the disease/abnormality.

It will be appreciated that the surgical access system and methodsdescribed herein have broad applications. The foregoing embodiments werechosen and described in order to illustrate principles of the methodsand apparatuses as well as some practical applications. The precedingdescription enables others skilled in the art to utilize methods andapparatuses in various embodiments and with various modifications as aresuited to the particular use contemplated. In accordance with theprovisions of the patent statutes, the principles and modes of operationof this disclosure have been explained and illustrated in exemplaryembodiments.

It is intended that the scope of the present methods and apparatuses bedefined by the following claims. However, it must be understood thatthis disclosure may be practiced otherwise than is specificallyexplained and illustrated without departing from its spirit or scope. Itshould be understood by those skilled in the art that variousalternatives to the embodiments described herein may be employed inpracticing the claims without departing from the spirit and scope asdefined in the following claims. The scope of the disclosure should bedetermined, not with reference to the above description, but shouldinstead be determined with reference to the appended claims, along withthe full scope of equivalents to which such claims are entitled. It isanticipated and intended that future developments will occur in the artsdiscussed herein, and that the disclosed systems and methods will beincorporated into such future examples. Furthermore, all terms used inthe claims are intended to be given their broadest reasonableconstructions and their ordinary meanings as understood by those skilledin the art unless an explicit indication to the contrary is made herein.In particular, use of the singular articles such as “a,” “the,” “said,”etc. should be read to recite one or more of the indicated elementsunless a claim recites an explicit limitation to the contrary. It isintended that the following claims define the scope of the invention andthat the method and apparatus within the scope of these claims and theirequivalents be covered thereby. In sum, it should be understood that theinvention is capable of modification and variation and is limited onlyby the following claims.

What is claimed is:
 1. A surgical access system, comprising: an outersheath defined by an open distal end and an open proximal end with ahollow body portion extending therebetween that defines a workingchannel; an imaging system; and a holding arrangement positioned betweenthe outer sheath and the imaging system and aligning the imaging systemwith the working channel of the outer sheath and maintaining a fixeddistance between the imaging system and the outer sheath, wherein theholding arrangement is defined by first and second ends, and wherein thefirst end has an attachment harness connected thereto, and wherein thesecond end has an outer sheath attachment disposed on a second endthereof, wherein the holding arrangement is defined by a pair ofalignment members arranged in an arc-shaped configuration between thefirst and second ends.
 2. The surgical access system of claim 1, whereinthe attachment harness is configured to connect to the imaging system.3. The surgical access system of claim 2, wherein the attachment harnesshas a semi-circular shape.
 4. The surgical access system of claim 1,wherein the imaging system is an exoscope.
 5. The surgical access systemof claim 1, further comprising an obturator defined by a proximal endand a distal end, wherein the obturator is defined by a tapered distaltip, wherein the obturator is selectively positionable within the outersheath such that the distal tip protrudes from the distal end of theouter sheath when in an introducing configuration.
 6. The surgicalaccess system of claim 5, further comprising a navigational element thatis seated within the obturator.
 7. The surgical access system of claim6, wherein the navigational element is centered within the obturator. 8.The surgical access system of claim 6, wherein a distal end of thenavigational element is axially offset from the distal tip of theobturator.
 9. The surgical access system of claim 6, further comprisinga locking member that is operatively connected to a proximal end of theobturator, the locking member selectively engaging the navigationelement to lock the navigation element against movement and to lock thenavigational element to the obturator.
 10. The surgical access system ofclaim 5, wherein the distal tip is sized to close off the distal openingof the outer sheath when in the introducing configuration.
 11. Thesurgical access system of claim 6, wherein the obturator furthercomprises a handle portion having a central access opening formed on aproximal end of the handle portion, the central access opening being incommunication with a central channel therein, the central channel sizedto receive the navigation element.
 12. The surgical access system ofclaim 11, wherein navigation element extends proximally from theobturator when in an operational position and is operatively connectedto a navigation system.
 13. The surgical access system of claim 1,wherein the imaging system includes a light source, and wherein thelight source is directed to the working channel of the outer sheath. 14.The surgical access system of claim 1, wherein the alignment members arespaced from each other and are arranged to be parallel to one another.15. The surgical access system of claim 1, further comprising areinforcement section positioned between the attachment harness and thealignment members, wherein the reinforcement section extends along anoutside surface of the image system.
 16. The surgical access system ofclaim 1, wherein the image system is axially fixed with respect to thedistal end of the outer sheath.